Z-2551-2026 Class I Ongoing
FDA device recall Z-2551-2026 was initiated by Baxter Healthcare Corporation on May 21, 2026 and is designated Class I. Reason for recall: There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the patient and ineffect… The recall status is ongoing. Affected quantity: 13881 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 8, 2026
- Initiation Date
- May 21, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13881 units
Product Description
Hillrom VOLARA System P.CIRCUIT 5KIT AC, (Single Patient Use Circuit), Model/Catalog Number REF M08474; Oscillation Lung Expansion Therapy, positive pressure breathing device
Reason for Recall
There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the patient and ineffective nebulization, which may affect the delivery of the prescribed treatment. The issue has been associated with improper locking of the nebulizer cup after adding medication during user setup.
Distribution Pattern
Worldwide distribution - US Nationwide and the country of Canada.
Code Information
UDI: 10887761981499; Lot Numbers: All lot numbers distributed beginning on 4/28/2025